Product Overview
[Drug Name]
Generic Name: Lansoprazole Enteric-Coated Tablets
Trade Name: Lansoprazole Enteric-Coated Tablets 15mg x 24 Tablets
Pinyin Code: LanSuoXing LanSuoLaZuoChangRongPian 15mg x 24 Tablets
[Main Ingredients]
The main ingredient of this product is lansoprazole.
[Properties]
This product is an enteric-coated tablet, appearing white or light yellow-brown after removing the coating.
[Indications/Main Functions]
Gastric ulcer, duodenal ulcer, reflux esophagitis, Zollinger-Ellison syndrome (gastrinoma).
[Specifications]
15mg*24 tablets
[Dosage and Administration]
For the treatment of gastric and duodenal ulcers, take 15-30mg orally once daily in the morning. For duodenal ulcers, continue for 4-6 weeks.
[Adverse Reactions]
Mild side effects, primarily dry mouth, dizziness, and nausea.
[Candida Contraindications]
Pregnant and lactating women should avoid use.
[Drug Interactions]
Lansoprazole may delay the metabolism and excretion of diazepam and phenytoin, increasing the peak plasma concentration of acetaminophen and shortening its duration.
[Precautions]
There is no experience with pediatric use.
[Pediatric Use]
The safety of this drug for pediatric use has not been established (there is very little clinical experience with pediatric patients).
[Use in Elderly Patients]
Generally speaking, elderly patients have reduced gastric acid secretion and other physiological functions. Observe carefully during use.
[Overdose]
Not yet known.
[Pharmacology and Toxicology]
1. This product is benzophenone. This imidazole compound, after oral absorption, is transferred to the gastric mucosa and converted into an active metabolite under acidic conditions. This active metabolite specifically inhibits the H+/K+-ATPase system of gastric parietal cells, thereby blocking the final step of gastric acid secretion. This product inhibits basal gastric acid secretion and gastric acid secretion under stimulated conditions in a dose-dependent manner. This product has no antagonistic effect on choline and histamine H2 receptors. 2. Genotoxicity: The results of the Ames test, the rat hepatocyte unscheduled DNA synthesis test, the mouse micronucleus test, and the rat bone marrow cell chromosomal aberration test were all negative. The results of the in vitro human lymphocyte chromosomal aberration test were positive. 3. Reproductive Toxicity: Oral administration of this drug at 150 mg/kg/day (equivalent to 40 times the human dose based on body surface area) did not affect reproductive capacity or reproductive behavior in rats. Teratogenicity studies showed that oral administration of this drug at 150 mg/kg/day in pregnant rats and 30 mg/kg/day in pregnant rats (equivalent to 16 times the human dose based on body surface area) did not cause fetal teratogenicity. This drug and its metabolites can be secreted in rat milk. 4. Carcinogenicity studies: Oral administration of this drug at 5 to 150 mg/kg/day for 24 months in SD rats showed that this drug induced enterochromaffin-like (ECL) cell proliferation and benign ECL in a dose-dependent manner. Cytomas: The frequency of intestinal metaplasia in the stomach of test animals increased. The incidence of testicular Leydig cell adenomas in male rats increased in a dose-dependent manner. CD-1 mice were given oral doses of 15 to 600 mg/kg/day of this product (equivalent to 2 to 80 times the human dose based on body surface area) for 24 months. This product induced ECL cell proliferation in a dose-dependent manner, and the incidence of liver tumors in treated mice increased. Tumor incidence in male mice at 300 and 600 mg/kg/day, and in female mice at 150 and 600 mg/kg/day, exceeded the historical tumor incidence range for this strain of mice. Mice given 75 to 600 mg/kg/day of this product developed rete testis adenomas.
